senior executive regulatory Affairs

8 - 10 years

8 - 12 Lacs

Posted:2 months ago| Platform: Naukri logo

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Work Mode

Work from Office

Job Type

Full Time

Job Description

To support and execute end-to-end regulatory documentation and review for site transfer projects, from data collation to submission.

Key Responsibilities:

  • Coordinate data collection from CFTs for pre submission and site transfer packages. Review all plant-related documents
  • Prepare and submit dossiers for product registrations in Europe, US, UK, Canada, Australia, Brazil markets, ensuring adherence to country-specific guidelines and requirements.
  • Prepare and maintain regulatory trackers.
  • Support query responses and internal audits related to site transfers.
  • Ensure documentation quality and compliance with ICH/FDA/EU/Health Canada guidelines.

Qualifications:

  • M. Pharm with 48 years of RA experience.
  • Hands-on in Module 3, eCTD components, and lifecycle submissions.
  • Familiarity with change management systems (Trackwise or similar).

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